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Clinical Trials/NCT04425720
NCT04425720
Completed
N/A

Use of Remote Patient Monitoring (RPM) Platform for COVID-19 Patient

Montefiore Medical Center1 site in 1 country300 target enrollmentSeptember 1, 2020
ConditionsCOVID

Overview

Phase
N/A
Intervention
Not specified
Conditions
COVID
Sponsor
Montefiore Medical Center
Enrollment
300
Locations
1
Primary Endpoint
Number of Monitored Versus Non-Monitored In-patient Admission
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The central hypothesis motivating this study is that remote patient monitoring (RPM) of infectious disease patients can efficiently facilitate self-isolation. Additionally, RPM can assist in more rapid identification of patients at risk, facilitate detection of patient deterioration, and enable early interventions, all of which play a vital role in resource utilization and outcomes.

Detailed Description

Aim-I To develop and test a clinical care pathway that can be utilized in similar epidemic conditions in the future. To study this aim, the investigators will be using the COVID-19 medical surge as a condition to evaluate the framework of delivering care through remote patient monitoring. The success of this care delivery model will be evaluated on ease of model implementation, patient satisfaction, clinical outcomes, and the utilization of shared decision making. Aim-II To evaluate remote patient monitoring for appropriate resource utilization in epidemic and pandemic conditions. To evaluate this aim, the investigators plan to compare the emergency department (ED) visits and in-patient admission of patients with and without wearable remote patient monitoring devices. Additionally, the investigators will compare the number of patients that required critical interventions (mechanical ventilation and ECMO) during the hospital stay. Aim III To evaluate the utilization of wearable technology for upfront predictions of patients that would require in-patient admissions. To evaluate this aim, patients who are diagnosed with COVID-19 and are undergoing self-quarantine will be closely monitored using a wearable device, and shared-clinical decisions will be made based on the monitored data and patient diary. The comparison group will be patients undergoing routine standard of care at the hospital. ED visits, in-patient hospital admissions, and patient satisfaction will be the outcome measures compared between the two groups. Aim IV To evaluate the association between early identification of critical, abnormal vital signs and the prevention of serious adverse events. To evaluate this aim, patients in the monitored group and non-monitored group will be compared for ED visits, in-patient admissions, length of hospital stay, and serious adverse events.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
December 10, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Covid-19 positive patient
  • Does not require in-patient admission

Exclusion Criteria

  • Allergic to sensor patch
  • Has implanted pacemaker
  • Has excessive sweating

Outcomes

Primary Outcomes

Number of Monitored Versus Non-Monitored In-patient Admission

Time Frame: 14 days

compare the number of in-patient admissions between the monitored and non-monitored patients

How Many Subjects Needed to Visit the Emergency Department

Time Frame: 14 days

compare the number of participants who visited Emergency Department between both arms

Length of Stay

Time Frame: 14 days

Length of stay of subject if hospitalized

How Many Completed the Patient Satisfaction Survey

Time Frame: 14 days

Survey given to patients who were monitored to ask about satisfaction with the program. A research associate calls enrolled subjects to determine their opinions having participated in the program.

How Many Subjects End up Requiring Mechanical Ventilation and ECMO

Time Frame: 14 days

How often does a subject end up getting mechanical ventilation or ECMO

Serious Adverse Events

Time Frame: 14 days

events requiring extended hospital stay

Study Sites (1)

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